Compliance Program 7348.810 BIORESEARCH MONITORING

SPONSORS, CONTRACT RESEARCH ORGANIZATIONS AND MONITORS Date of Issuance: March 11, 2011 Guidance for FDA Staff This document is intended to provide guidance. It represents the Agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind Food and Drug Administration (FDA) or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.   Cover Page Part I Background Part II Implementation Part III Inspectional Part IV Analytical Part V Regulatory/Administrative Part VI References and Program Contact Part VII Headquarters' Responsibilities CP 7348.810  as an Adobe Acrobat (.pdf) file